Circulating nucleic acids (CNAs) in body fluids offer unique opportunities for early diagnosis of clinical conditions. Specific clinical biomarkers have the potential to revolutionize diagnosis and treatment of various medical conditions, such as abnormal pregnancies. The challenge of diverse biomedical research fields has been to identify biomarkers in body fluids, such as serum. In recent years it has become clear that both cell-free DNA and mRNA are present in serum, as well as in other body fluids, and represent potential biomarkers. However, monitoring the typically small amounts of these CNAs in body fluids requires sensitive detection methods, which are not currently clinically applicable.
microRNAs (miRNAs, miRs) have emerged as an important novel class of regulatory RNA, which has profound impact on a wide array of biological processes. These small (typically 17-24 nucleotides long) non-coding RNA molecules can modulate protein expression patterns by promoting RNA degradation, inhibiting mRNA translation, and also affecting gene transcription. miRs play pivotal roles in diverse processes such as development and differentiation, control of cell proliferation, stress response and metabolism. There are currently about 850 known human miRs.
Preeclampsia, complicating 3-5% of pregnancies, is associated with substantial risks for both the mother and the fetus. Although many theories exist for the etiology and pathogenesis of preeclampsia, its direct etiology remains unidentified. There has been little progress in the treatment of this disorder; the cure remains delivery of the fetus and removal of the placenta.
Effective management strategies for identifying and treating preterm labor are required to prevent preterm birth. Early births resulting from preterm labor result in a heavy burden of infant mortality and morbidity. Preterm birth is a factor in three-quarters of neonatal mortality and one-half of long-term neurologic impairment in children.
Early detection and management of preterm labor helps to prevent preterm birth and its potential neonatal sequelae, which include respiratory distress syndrome, sepsis, intraventricular hemorrhage, necrotizing enterocolitis, patent ductus arteriosus, and hyperbilirubinemia; however, widespread treatment of women with signs and symptoms of preterm labor has not significantly reduced the prevalence of preterm birth, underscoring the need to improve current methods for detecting preterm labor.
There is an unmet need for a reliable method for identifying subjects at risk of developing a complication of pregnancy, such as preeclampsia or preterm labor.